On 30 May 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion, recommending the granting of marketing authorisation for FGK’s Avzivi®, biosimilar to Genentech’s Avastin® (bevacizumab).
The applicant for Avzivi in the EU is FGK Representative Service GmbH, which provides legal representative services to sponsor companies not based in the EU. However, Bio-Thera is the developer of the product, which is to be marketed by Sandoz (including in the EU) pursuant to a licence and commercialisation agreement entered between Bio-Thera and Sandoz in September 2021.
Avzivi® was FDA approved in December 2023.